US HIFU hires Michael Klein as its new CEO

The Charlotte-based medical-device company is developing technology that utilizes high-intensity focused ultrasound — or HIFU — to treat prostate cancer.

Klein, who also has been appointed to US HIFU’s board of directors, has more than 30 years of experience in the oncology and medical-device industry. He most recently was president of the radiation oncology division of Roper Industries Inc. He also has led R2 Technology and Xoft, both of which developed cancer technologies.

Klein has experience overseeing clinical trials and interacting with the U.S. Food and Drug Administration. He will lead US HIFU’s efforts to attain FDA approval for its device, called the Sonablate 500. The company hopes to gain approval in early 2013.

Klein also will oversee the company’s other operations, including market development for the Sonablate outside of the United States and the Sonatherm 600, another medical device.

Steve Puckett Jr., who had been CEO, shifted to a business-development role. And his father, MedCath Corp. founder Steve Puckett Sr., took over as interim CEO. In addition, Tom Mendell, formerly a senior partner of Goldman Sachs Co.’s private-equity fund, was named interim chairman of the board. Both are US HIFU investors.

At the time, Puckett Jr. said the company was looking for a CEO who has managed successful commercialization efforts and has good relationships with analysts in the medical-device sector. “We’re getting all the infrastructure in place to really be a major commercial company,” he said.

Under the government’s EB-5 program, those investors stand to gain more than an ownership stake in US HIFU; they’ll also receive a conditional green card that’s valid for two years. And at the end of those two years, they will be able to apply for permanent U.S. residency, if requirements related to the investment — such as job creation — are met.